Reviewing a patent infringement action arising under the Hatch-Waxman 35 U.S.C. § 271(e)(2) framework, but based on method-of-use claims not covering the indications for which the defendants were seeking U.S. Food and Drug Administration (FDA) approval, the U.S. Court of Appeals for the Federal Circuit reversed the district court’s finding of lack of subject-matter jurisdiction, but upheld the district court’s finding that the patent owner to state a claim upon which relief could be granted.  AstraZeneca Pharmaceuticals LP v. Apotex Corp., Nos. 11-1182; -1183; -1184; -1185; -1186; -1187; -1188; -1189; -1190 (Fed. Cir., Feb. 9, 2012) (Lourie, J.).  The Federal Circuit also affirmed the district court’s conclusion that those claims premised on presumed future labeling amendments (that would be directed to claimed methods-of-use) were not ripe for adjudication.

Seeking FDA-approval for generic versions of AstraZeneca’s cholesterol-lowering drug CRESTOR®, while aiming to avoid infringement of the two Orange Book listed method-of-use patents, several generic companies, including Apotex, sought Abbreviated New Drug Application (ANDA) approval for non-patented indications of this blockbuster medication. Accordingly, rather than filing Paragraph IV certifications with respect to the two method patents asserted in this suit, the defendants made statements under 21 U.S.C. § 355(j)(2)(A)(viii), or so-called Section viii statements, indicating that their ANDAs excluded all uses claimed in the Orange-Book-listed patents. AstraZeneca nevertheless filed patent infringement suits against the defendants under 35 U.S.C. § 271(e)(2), asserting infringement by alleging that off-label prescribing would nevertheless occur and would be directed to patented uses.  AstraZeneca also alleged that the FDA would presumably ultimately require amendments to defendants’ labels that would be directed to patented uses.

On the issue of subject-matter jurisdiction, the Federal Circuit concluded that the district court had erred in finding AstraZeneca’s claims failed due to lack of subject-matter jurisdiction. Rather, the Federal Circuit explained that under the low threshold to obtain subject-matter jurisdiction (that it had set forth in Allergan v. Alcon Labs) AstraZeneca’s allegation that the defendants’ ANDAs filings infringed their listed patents under § 271(e)(2) was sufficient to convey subject-matter jurisdiction under this “highly artificial act of infringement” created by Congress.  

However, the Federal Circuit agreed with the district court that AstraZeneca had failed to state a claim upon which relief could be granted, because seeking approval for uses not covered by a patent does not constitute an act of infringement. The Court, citing the plain language of the statute and its decision in Warner-Lambert v. Apotex (IP Update, Vol. 6, No. 2), rejected AstraZeneca’s interpretation of § 271(e)(2) to encompass infringement based on the filing of an ANDA for non-patented uses of the drug. The Court rejected AstraZeneca’s argument that “market realities” would dictate that CRESTOR would be prescribed for unpatented uses. The Court concluded that such speculative arguments, if successful, would effectively bar generic manufacturers from entering the market, noting that even if the patented off-label use were to occur, it would be beyond the scope of § 271.

Finally, the Federal Circuit upheld the district court’s conclusion that AstraZeneca’s allegation that the FDA will, in the future, require amendments to defendants’ labels to include patented indications as not ripe for adjudication, again citing to Warner-Lambert.